Catalog Number

-

Brand Name

ECLIPSE

Version/Model Number

PRP2600-10ML

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

e1abea76-d221-4449-979a-ecdbe312dd8e

Public Version Date

March 21, 2022

Public Version Number

1

DI Record Publish Date

March 11, 2022

Package DI Number

16935550810100

Quantity per Package

100

Contains DI Package

06935550810103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box